A Light-Based Treatment Is Now FDA Approved for a Common Skin Cancer

Basal cell carcinoma is the most common form of skin cancer, and most people treat it with some form of surgery. On Sept. 14, 2026, the Food and Drug Administration (FDA) approved a nonsurgical option for one type: Ameluz (aminolevulinic acid hydrochloride) gel with red-light photodynamic therapy (PDT) for superficial basal cell carcinoma in adults.

Ameluz PDT was already approved for actinic keratosis, a precancerous skin condition that can sometimes develop into squamous cell carcinoma. This is the first time the FDA has approved a photodynamic therapy to treat a skin cancer, giving some patients an option that does not involve cutting into the skin.

While basal cell carcinoma rarely spreads to other parts of the body, it can grow into surrounding tissue and cause damage if left untreated. Because of this, treatment typically focuses on completely removing or destroying the cancer while preserving as much healthy skin as possible. Surgery, including procedures such as Mohs surgery, remains a common approach. The new approval could provide another option for certain patients, particularly those with superficial tumors in areas where minimizing scarring may be important.

How It Works

PDT is a two-step treatment done in a dermatologist's office. First, a gel containing aminolevulinic acid is applied to the lesion and the surrounding skin. The medication is taken up more readily by abnormal cells, including cancer cells, and causes them to become sensitive to certain wavelengths of light.

After a waiting period, the area is exposed to a red-light lamp. The light activates the medication, triggering a chemical reaction that damages and destroys the targeted cells. Because the treatment is designed to concentrate its effects on abnormal cells, it can treat the cancer without making an incision or removing a section of skin.

In the phase 3 trial supporting the approval, patients could receive up to two treatment cycles. Each cycle consisted of two PDT sessions performed one to two weeks apart. This means treatment does not necessarily happen in a single visit, and patients should discuss the expected number of sessions with their dermatologist.

What the Trial Found

The FDA's approval was based on a phase 3 trial that included 187 adults with superficial basal cell carcinoma located on areas including the face, forehead, bald scalp, arms and legs, neck and trunk.

Twelve weeks after treatment, researchers found:

• About 66% of patients had their main lesion completely cleared, confirmed both by a clinical examination and laboratory testing of tissue, compared with about 5% of patients who received a placebo gel.
• 83% of patients had lesions that appeared completely clear during a clinical examination, compared with 21% of those who received placebo.
• 89% of treated lesions had a good or very good cosmetic result.

These results suggest that PDT can eliminate visible and microscopic signs of superficial basal cell carcinoma in many patients while also producing favorable cosmetic results. However, the short-term results do not necessarily mean the cancer will never return. Researchers are continuing to follow patients to better understand how durable the treatment's effects are over time.

The most common side effects were reactions at the treatment site, including redness, swelling and stinging or burning during the light treatment. These reactions are related to the treatment's effect on the targeted tissue and may be uncomfortable while the medication is being activated.

Who It's For, and Who It Isn't

This approval is specifically for superficial basal cell carcinoma, a type that is limited primarily to the upper layers of the skin. Not every basal cell carcinoma falls into this category, so the location, size and depth of a tumor will help determine whether PDT is appropriate.

The treatment isn't approved for nodular or deeper basal cell carcinomas, which may extend farther into the skin and usually require a treatment capable of removing or destroying deeper tissue.

A dermatologist may also consider other factors, including the size and location of the cancer, whether it has been treated before and the patient's overall health and treatment preferences.

How It Compares With Surgery

Surgery remains one of the most established and reliable ways to treat basal cell carcinoma. Depending on the cancer, this may include standard surgical removal or Mohs surgery, which allows a surgeon to examine the tissue as it is removed to help ensure that the cancer has been completely eliminated.

PDT offers a different approach. Instead of cutting out the tumor, it uses medication and light to destroy the cancerous cells. That means there is no surgical incision or need for stitches, and the treatment may result in less visible scarring.

Cosmetic outcomes can be particularly important when basal cell carcinoma develops on highly visible areas such as the face or forehead. PDT may also be appealing to some patients who have multiple superficial lesions or who are looking for a nonsurgical treatment option.

However, avoiding surgery does not necessarily mean PDT is the better choice for every patient. Earlier studies of photodynamic therapy with a similar medicine found that superficial basal cell carcinomas came back somewhat more often after PDT than after surgical removal. The ongoing follow-up from the phase 3 trial will provide additional information about how often treated cancers return over time.

For that reason, patients should view PDT as another treatment option for a specific type of basal cell carcinoma rather than a replacement for surgery in all cases.

Questions to Ask Your Dermatologist

If you've been diagnosed with basal cell carcinoma, your dermatologist can help determine which treatment makes the most sense based on the characteristics of your cancer. Some questions to consider include:

• Is my basal cell carcinoma the superficial type?
• Would PDT or surgery give me the best chance of completely treating the cancer?
• How does my cancer's location affect my treatment options?
• How many PDT sessions would I need, and what should I expect during and after treatment?
• What side effects should I expect from the light treatment?
• How will we monitor the area afterward to make sure the cancer has not returned?
• Is PDT covered by my insurance?

References

1. Biofrontera. "Biofrontera Announces FDA Approval of Ameluz Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma." GlobeNewswire, Sept. 14, 2026.
2. HCPLive. "Ameluz Treatment Becomes First FDA-Approved PDT for Skin Cancer." Sept. 14, 2026.
3. Cancer Therapy Advisor. "Ameluz Plus Red Light PDT Approved for Superficial Basal Cell Carcinoma." Sept. 17, 2026.
4. Targeted Oncology. "FDA Accepts sNDA for Photodynamic Therapy in Superficial Basal Cell Carcinoma." August 2026.
5. ClinicalTrials.gov. "Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas." NCT02639117.

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